NCT00961805

Brief Summary

The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia. Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

August 19, 2009

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

1 month

First QC Date

April 30, 2009

Results QC Date

April 30, 2009

Last Update Submit

August 19, 2009

Conditions

Keywords

FibromyalgiaTreatmentDanceRandomized controlled studyExercise

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale for Pain

    score between 0 and 100 where 0 is no pain and 100 in unbearable pain

    baseline, after 16 weeks and after 32 weeks

Secondary Outcomes (12)

  • Function - 6 Minute Walk Test

    baseline, after 16 weeks and after 32 weeks

  • Quality of Life - Fibromyalgia Impact Questionnaire

    baseline, after 16 weeks and after 32 weeks

  • Quality of Life - SF-36 -Functional Capacity

    baseline, after 16 weeks and after 32 weeks

  • Quality of Life - SF-36 - Physical Limitation

    baseline, after 16 weeks and after 32 weeks

  • Quality of Life - Sf-36 - Pain

    baseline, after 16 weeks and after 32 weeks

  • +7 more secondary outcomes

Study Arms (2)

Dance Group

EXPERIMENTAL

Belly dance

Behavioral: Dance

Control Group

NO INTERVENTION

Waiting list

Other: Control Group

Interventions

DanceBEHAVIORAL

Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Dance Group

The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • classification of fibromyalgia based on the criteria of the American College of Rheumatology
  • female gender
  • aged between 18 and 65 years

You may not qualify if:

  • not having altered treatment in previous three years
  • having signed a term of informed consent
  • patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-090, Brazil

Location

Related Publications (1)

  • Baptista AS, Villela AL, Jones A, Natour J. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):18-23. Epub 2012 Dec 14.

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Andreia S Baptista, PT
Organization
Federal University of Sao Paulo

Study Officials

  • Andreia S Baptista, PT

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR
  • Jamil Natour, MD

    Federal University of São Paulo

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2009

First Posted

August 19, 2009

Study Start

August 1, 2007

Primary Completion

September 1, 2007

Study Completion

November 1, 2008

Last Updated

August 25, 2009

Results First Posted

August 19, 2009

Record last verified: 2009-08

Locations